Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.
Reported: April 14, 2021 Initiated: February 25, 2021 #Z-1344-2021
Product Description
Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.
Reason for Recall
Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a blood leak at the boot, elbow, or in the channel on the separation chamber of the centrifuge pack.
Details
- Recalling Firm
- Fenwal Inc
- Units Affected
- 2466 units
- Distribution
- US Nationwide distribution in the states of GA, TX, TN, MD, CA, KS, MN, MA, NM, NC, LA, CO, KY, NV, PA, UT, MI, NJ, IL, MD, OH, NY, FL.
- Location
- Lake Zurich, IL
Frequently Asked Questions
What product was recalled? ▼
Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.. Recalled by Fenwal Inc. Units affected: 2466 units.
Why was this product recalled? ▼
Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a blood leak at the boot, elbow, or in the channel on the separation chamber of the centrifuge pack.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 14, 2021. Severity: Moderate. Recall number: Z-1344-2021.
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